Kornimate/medical-research-clean huggingface dataset:
pacing activity self-management for patients with chronic fatigue syndrome

Conditions: Chronic Fatigue Syndrome

Summary: given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (cfs), it is examined whether physical behavior and health status of patients with cfs improve in response to a pacing self-management program. the effects of pacing will be compared with those observed when applying relaxation therapy to patients with cfs.

given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (cfs), it is examined whether physical behavior and health status of patients with cfs improve in response to a pacing self-management program. the effects of pacing will be compared with those observed when applying relaxation therapy to patients with cfs. according to the power calculation, 36 patients fulfilling the 1994 centre for disease control and prevention criteria for the diagnosis of chronic fatigue syndrome (cfs) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. all treatments will be delivered by occupational therapists or physiotherapists. one treatment session lasts for about 45 minutes each. outcome measures include the canadian occupational performance measure (copm), medical outcomes short form 37 health status survey (sf-36), checklist individual strength (cis), cfs symptom list and autonomic activity at rest and following 3 activities of daily living (writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs). for measuring autonomic activity, the nexus 10 device (mind media, the netherlands) will be used. skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). electrodes will be placed on the left hand in all patients.

Eligibility criteria:
inclusion criteria: * adult * age range between 18 and 65 years of age * female gender * willing to sign informed consent form * fulfilling the 1994 centre for disease control and prevention criteria for the diagnosis of chronic fatigue syndrome exclusion criteria: - not fulfilling each of the inclusion criteria listed above.

Keywords: pacing activity management relaxation physiotherapy occupational therapy autonomic nervous system
comparison of distally based sural artery and supramalleolar flap for coverage of dorsum of foot and ankle defects

Conditions: Open Wound of Lower Limb

Summary: our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. the patients' information were collected through medical records and analyzed through spss

in this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed tool . this tool contains 4 parameters i.e., activity of daily living, coverage of defect, cosmetic appearance of skin post flap, and weight bearing status. a score was given to each parameter and on the basis of these scores, long term outcome were analyzed of each patient

Eligibility criteria:
inclusion criteria: * only defects of foot and ankle around dorsum and perimalleolar areas were included. exclusion criteria: * the defects reconstructed with other local flaps and free flaps were excluded from this review

Keywords: soft tissue injuries, fasciocutaneous flaps, survival rate
evaluation of efficacy and toxicity of nivolumab monotherapy for advanced non-small cell lung cancer after first-line treatment failure based on second-generation sequencing and liquid chip platform

Conditions: Lung Cancer Non-small Cell Stage IV

Summary: in order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. the second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。

in order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. the second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。

Eligibility criteria:
inclusion criteria: * subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study. * ps \> 2, lung cancer in the elderly (less than 65 years old). * subjects' characteristics and target disease characteristics histologically or cytologically diagnosed as nsclc (sq or nsq) and with stage iiib/iv tumors (international association for the study of lung cancer staging manual in thoracic oncology, version 8) or multimodal therapy (radiotherapy, surgical resection) subjects who relapsed or developed disease after radical chemoradiotherapy for locally advanced diseases. * prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatmen exclusion criteria: * women with a positive pregnancy test at enrollment or prior to administration of study medication * participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug * participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period * participants with carcinomatous meningitis other protocol defined inclusion/exclusion criteria could apply

Keywords: ngs cytokine efficacy side effect
liver status in psychiatric inpatients

Conditions: Psychiatric Illness

Summary: adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease). the evaluation of these liver disorders in psychiatric inpatients remains very little explored in france, contributing to the poor overall medical status of psychiatric patients. the liverspin study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology

the liverspin study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease. all hospitalized patients can potentially be recruited. they will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. for the determination of biological analyses, a blood sample will be taken following inclusion as well as a fibroscan examination.

Eligibility criteria:
inclusion criteria: * age \>18 years old * social insurance * current hospitalization in any psychiatric unit of the participating center * adult or legal representative who has given written and informed consent to participate in the study. by default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative) * information given to the curator(for people under curatorship) exclusion criteria: * - clinical state of the patient which do not allow the collection of study data (according to the investigator)
effect of ferrlecit® versus oral iron on iron deficient chronic kidney disease (ckd) patients receiving erythropoietic agents

Conditions: Anemia, Iron-Deficiency; Kidney Failure, Chronic

Summary: this study compares the effect of ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as procrit® and aranesp®.


Eligibility criteria:
inclusion criteria: * moderate to severe anemia * iron deficiency * moderate to severe chronic kidney disease * receiving therapy with erythropoietic agent exclusion criteria: * receiving dialysis * known sensitivity to ferrlecit® or any of its components * clinically unstable

Keywords: iron deficiency anemia chronic kidney disease erythropoietic agents sodium ferric gluconate anemia, iron-deficiency/drug therapy/etiology kidney failure, chronic/blood/complications/therapy erythropoietin, recombinant/adverse effects/therapeutic use
vitamin d, c-reactive protein and insulin resistance

Conditions: Diabetes; Low-intensity Chronic Inflammation; Insulin Resistance

Summary: randomized, double blind, placebo-controlled clinical trial of vitamin d supplementation (cholecalciferol, 4,000 iu/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. the objective was to evaluate the effect of vitamin d supplementation on c-reactive protein (crp) and insulin resistance in women with type 2 diabetes mellitus (t2dm). the trial was conducted from march to october 2008 at the hospital of the mexican social security in cuernavaca, mexico.

methods. randomized, double blind, placebo-controlled clinical trial. we selected 104 postmenopausal women, ages 45 to 65, with uncomplicated t2dm and bmi ≥25. women with history of kidney or liver disease, bmi\>40, autoimmune disease or cancer were not included in the study. participants were randomly assigned to receive either a capsule containing 4,000 iu of vitamin d3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months. outcome variables were serum crp, measured with a high-sensitivity assay (nephelometry), and homa-ir. serum vitamin d (25-oh-d) was measured by hplc. outcome variables were measured at baseline, and 3 and 6 months thereafter. all participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month. baseline results. mean age was 56.8 ± 5.1 y. baseline bmi was 30.7 ± 3.9. median crp concentration was 5.0 mg/l (interquartile range: 1.0, 8.5). homa index at baseline was 7.13 ± 3.8. serum 25-oh-d concentration at baseline was 54.5 ± 15.7 nmol/l (\~22 ng/ml). almost 94% of patients had baseline serum 25-oh-d levels \<80 nmol/l, and 25% were below 40 nmol/l. no one had levels \<20 nmol/l. there were no statistical differences on important variables by treatment group at the onset of study.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus w/ \< 10 yrs of diagnosis * postmenopausal * overweight or obesity (bmi \>=25) * treated with metformin exclusion criteria: * bmi \>=40 * liver or kidney disease * other important chronic disease: i.e. cancer, autoimmune. * receiving insulin

Keywords: vitamin d diabetes c-reactive protein insulin resistance
establishment of online registration platform for unruptured intracranial aneurysms based on 100 regional medical centers in china and population follow-up study

Conditions: Intracranial Aneurysm

Summary: in this study, 20 regional neurosurgery centers across the country will be included, and the study cohort will be constructed on the basis of the iarp-cp cohort.the artificial intelligence platform was used to analyze the clinical, morphological, hemodynamics, aneurysm wall characteristics and other factors of unruptured aneurysms, as well as the relationship between these factors and the risk of aneurysm instability, seek the potential risk factors, and finally establish a multi-dimensional prediction model of rupture risk of intracranial aneurysms.


Eligibility criteria:
inclusion criteria: 1. 18-75 years old; 2. at least one unruptured intracranial aneurysm was found by cta; 3. no relevant symptoms, receiving non-operative and conservative observation treatment; 4. signing the informed consent. exclusion criteria: 1. other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors; 2. fusiform or dissecting aneurysms; 3. traumatic, mycotic and atrial myxoma associated aneurysms; 4. suffering from systemic connective tissue diseases, such as polycystic kidney disease; 5. expectant survival of no more than 3 years due to other diseases or poor general conditions; 6. patients refuse to follow up or cannot communicate with them due to mental diseases; 7. pregnant women or participating in other aneurysm related studies.

Keywords: intracranial aneurysm online registration platform artificial intelligence multidimensional model
gore® tag® thoracic endoprosthesis french mandatory registry

Conditions: Aortic Aneurysm, Thoracic; Descending Thoracic Aortic Dissection; Aortic Diseases; Aorta Thoracic; Traumatic Rupture; Penetrating Ulcer

Summary: this is a french registry mandated by the french national health authority assessing long-term (5-years) safety of the gore® tag® thoracic endoprosthesis treating diseases of the thoracic aorta.

endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. the french national health authority (has) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.

Eligibility criteria:
inclusion criteria: * patient where a gore® tag® or conformable gore® tag® thoracic endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta. * patient who had previously consented to the collection and processing of personal medical data. * patient older than 18 years at the time of treatment. exclusion criteria: * patients who have already received treatment with a thoracic endoprosthesis other than the gore® tag® or conformable gore® tag® thoracic endoprosthesis and for whom 'revision' or reintervention is required. * patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).
hw006 lateral thoracotomy

Conditions: Left Sided Heart Failure

Summary: this is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the heartware hvad system and enrolled in the interagency registry for mechanically assisted circulatory support (intermacs®) protocol and database. all participating centers are current intermacs® sites in good standing and follow the intermacs® protocol and procedures.


Eligibility criteria:
inclusion criteria: 1. must be ≥19 years of age at time of informed consent to participate in the intermacs® registry. 2. subject receives a heartware hvad (the device should be the subject's first vad implant). 3. subject signed an intermacs® informed consent if required by local irb policy. 4. subject signed a heartware informed consent. exclusion criteria: 1. subject is incarcerated (prisoner). 2. subject did not sign the informed consent at sites where waiver of consent was not granted. 3. body surface area (bsa) \< 1.2 m\^2. 4. prior cardiac transplant or cardiomyoplasty. 5. subject is receiving a bivad. 6. subject is receiving the device as an rvad. 7. subject data is generated from non- intermacs® centers. 8. pediatric subjects (\< 19 years of age). 9. subjects who receive a temporary lvad 10. subjects whose device strategy is listed as "destination therapy" at the time of implant. 11. severe right heart failure 12. aortic insufficiency or mechanical aortic valve. 13. planned concomitant procedure (e.g.valve repair or replacement, cabg, septal defect repair). 14. known lv thrombus.
neoadjuvant study of pyrotinib and trastuzumab plus vinorelbine in trastuzumab-refractory her2-positive breast cancer.

Conditions: HER2 Positive Breast Cancer

Summary: this study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus vinorelbine given as neoadjuvant treatment in trastuzumab-refractory her2 positive early stage or locally advanced breast cancer.

neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. in recent years, the anti-her2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. pyrotinib is an oral tyrosine kinase inhibitor targeting both her-1 and her-2 receptors. based on previous clinical studies, we designed the study to explore the possibility of pyrotinib in combination with trastuzumab plus vinorelbine given as neoadjuvant treatment in her2 positive early stage or locally advanced breast cancer.

Eligibility criteria:
inclusion criteria: * 1. female patients, 18 years ≤ age ≤ 75 years. 2. performance status- eastern cooperative oncology group (ecog) 0-1. 3. histologically confirmed invasive breast cancer:early stage or locally advanced,primary tumour greater than 2 cm diameter 4. her2 positive (her2+++ by ihc or fish+) 5. subjects received neoadjuvant therapy with trastuzumab 2 weeks post-imaging evaluation patients with a price of pd or sd. 6. known hormone receptor status. 7. required laboratory values including following parameters: anc: ≥ 1.5 x 10\^9/l;platelet count: ≥ 100 x 10\^9/l;hemoglobin: ≥ 9.0 g/dl;total bilirubin: ≤ 1.5 x upper limit of normal (uln);alt and ast: ≤ 1.5 x uln (or ≤ 5×uln in patients with liver metastases);bun and creatine clearance rate: ≥ 50 ml/min;lvef: ≥ 50%;qtcf: \< 470 ms for female and \< 450 ms for male. 8. signed the informed consent form prior to patient entry. exclusion criteria: - 1. metastatic disease (stage iv) or inflammatory breast cancer. 2. previous or current history of malignant neoplasms, except for curatively treated:basal and squamous cell carcinoma of the skin,carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease:known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. unable or unwilling to swallow tablets.

Keywords: trastuzumab-refractory
evaluation of pku sphere in maternal pku

Conditions: Maternal Phenylketonuria

Summary: this observational study aims to recruit females, aged 16 years and over, with phenylketonuria (pku) or hyperphenylalaninemia (hyperphe) following dietary management advice pre-conception and/or during pregnancy, who are willing to take pku sphere as part of their dietarty management.

the aim of this study is to observe dietary management and metabolic control in women taking pku sphere pre-conceptually and/or during pregnancy. to do this the following data points will be captured: * blood spot phenylalanine and tyrosine levels to measure metabolic control * changes to dietary management and any adaptations arising from incorporating pku sphere * compliance/adherence of patients to their recommended amount of protein substitute prescription. * tolerance of pku sphere with respect to gastrointestinal (gi) symptoms and pregnancy associated nausea and vomiting. * acceptability of concurrent protein substitute(s) (if applicable). * nutritional status and weight management. * routine standard of care data on the final pregnancy outcome and postpartum.

Eligibility criteria:
inclusion criteria: * diagnosis of phenylketonuria (pku) or hyperphenylalaninemia (hyperphe) which requires dietary management during pre-conception and/or pregnancy. * aged 16 years and above. * following dietary management advice pre-conceptually and/or during pregnancy, aiming for phenylalanine levels of 120-250µmol/l. * prior positive pku sphere taste test completed as part of routine care. * chosen to take part or full requirement of protein substitute as pku sphere pre-conceptually and/or during pregnancy. * willingly given, written, informed consent from patient. * participant is, in the opinion of the investigator, able to participate and can comply with the study protocol. exclusion criteria: * conception of pregnancy without commencement of phe-restricted diet and blood phenylalanine not maintained within target range by 10 weeks' gestation. * patients with known soya, milk or fish allergies / intolerance. * intake of pegvaliase or large neutral amino acids within 30 days prior to screening visit. * patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.

Keywords: maternal pku phenylketonuria gmp glycomacropeptide
panretinal photocoagulation during vitrectomy for diabetic vitreous hemorrhage

Conditions: Diabetic Vitreous Hemorrhage

Summary: in this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in pdr subjects naïve to prp undergoing ppv for the indication of vh.

enrolled patients will be randomized into 1 of 2 possible treatment groups: group a patients underwent endolaser prp with a range of 200-300 shots during ppv, whereas group b patients underwent endolaser prp with a range of 500-600 shots during ppv. simple randomization will allocate subjects into treatment groups during ppv. once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser prp, a coin toss simulation program will randomize subjects into treatment groups.

Eligibility criteria:
inclusion criteria: * the subject has type i or ii diabetes mellitus * the age of the subject is \> 18 years old * snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye * proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision * the subject is panretinal photocoagulation-naïve * the vitreoretinal adhesion is grade 0 or 1 according to the classification system published by ahn et al in the research eye exclusion criteria: * the research eye had formerly undergone anterior or posterior vitrectomy. * an opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.) * optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.) * amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye * neovascular glaucoma with an elevated intraocular pressure (\> 30 mm hg) is present in the research eye * uncontrolled systemic hypertension (systolic \> 200 mmhg or diastolic \> 120 mmhg) is present